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311
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Job Code

1712484

Dhanuka - International Registration Manager

Dhanuka Agritech.10 - 15 yrs.Gurgaon/Gurugram
Posted 1 month ago
Posted 1 month ago

Role Overview:

This role demands deep expertise in international agrochemical regulations, dossier preparation, stakeholder management, and coordination with cross-functional teams to drive timely registrations and maintain regulatory compliance throughout the product lifecycle.

Key Responsibilities:

Regulatory Strategy & Market Access:

- Develop and execute regulatory strategies to obtain and maintain registrations for agrochemical products in international markets.

- Evaluate regulatory pathways, market entry requirements, and registration timelines for new product introductions.

- Provide strategic guidance on regulatory implications impacting business expansion and commercialization plans.

- Monitor evolving global regulatory frameworks and assess their impact on product portfolios.

Registration & Dossier Management:

- Lead the preparation, compilation, review, and submission of regulatory dossiers for agrochemical product registrations.

- Manage end-to-end registration activities for technicals, formulations, new active ingredients, and label amendments.

- Coordinate data generation plans and ensure availability of required studies to support submissions.

- Maintain registration schedules, databases, and documentation to ensure timely approvals and renewals.

- Oversee lifecycle management activities including renewals, re-registrations, label expansions, and regulatory updates.

Regulatory Compliance:

- Ensure compliance with international regulatory standards and country-specific requirements governing crop protection products.

- Interpret regulatory guidelines and communicate compliance requirements to internal stakeholders.

- Review product labels, safety data sheets, and technical literature to ensure regulatory accuracy and compliance.

- Support regulatory inspections, audits, and responses to agency queries.

Cross-Functional Collaboration:

- Collaborate closely with R&D, toxicology, environmental science, product development, stewardship, manufacturing, and legal teams to collect and validate data required for submissions.

- Work with external consultants, contract research organizations, and regulatory agencies to facilitate registration processes.

- Provide regulatory expertise during product development and commercialization stages.

- Serve as the primary point of contact for regulatory authorities and external stakeholders.

Regulatory Intelligence:

- Track changes in global agrochemical regulations, residue requirements, environmental standards, and toxicological assessments.

- Analyze emerging regulatory trends and proactively recommend mitigation strategies.

- Support management with regulatory risk assessments and strategic recommendations.

Desired Candidate Profile:

- Minimum 10 years of experience in International Regulatory Affairs and Registration within the Agrochemical or Crop Protection industry.

- Proven experience managing registrations across multiple international markets.

Technical Competencies:

- Strong understanding of global agrochemical regulatory frameworks and registration processes.

- Expertise in preparing and reviewing international regulatory dossiers.

- Experience handling submissions related to technical products, formulations, active ingredients, and renewals.

- Knowledge of international regulatory guidelines, data compensation requirements, and stewardship practices.

- Excellent documentation, scientific writing, and regulatory communication skills.

Behavioral Competencies:

- Strong analytical and problem-solving capabilities.

- Excellent stakeholder management and influencing skills.

- Ability to manage multiple projects simultaneously in a fast-paced environment.

- High attention to detail and commitment to regulatory excellence.

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Posted by

Job Views:  
311
Applications:  34
Recruiter Actions:  0

Job Code

1712484

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